Brief Title
Maternal Antibody in Milk After Vaccination
Official Title
Maternal Antibody in Milk After Vaccination
Brief Summary
Single-centre observational pilot study exploring pertussis specific antibody concentration in the breastmilk of women vaccinated against pertussis in pregnancy at different gestational ages. This study is made up of two stages: first stage to confirm recruitment methods and optimise the laboratory assay and a second stage to complete recruitment for the pilot study.
Detailed Description
Pertussis disease is a highly infectious respiratory illness caused by Bordetella pertussis, which can cause significant morbidity and mortality. There has been an increase in cases in many high income countries with high vaccination coverage and in an attempt to control this, antenatal vaccination programmes have been introduced in several countries, including the UK. Vaccination in pregnancy is a strategy which seeks to boost the maternal antibody levels, increase the placental transfer of antibody and consequently increase the antibody levels in the infant. Human breast milk is a dynamic source of nutrition for the infant and is made up of many immunologically active components including antibody. The principal antibody in breastmilk is IgA and it has been shown that the amount of disease specific antibody in breastmilk can be increased by vaccination in pregnancy for a number of pathogens including pertussis. Secretory IgA (sIgA) plays an important role in immune exclusion in which it blocks adhesion of a pathogen onto a mucosal surface. As the first step of pertussis pathogenesis is the adhesion of bacteria to the ciliated respiratory epithelium in the nasopharynx and trachea there is a clear biological rationale for the hypothesis that receiving breast milk containing more IgA could enhance neonatal immunity and consequently the protective effects of vaccination in pregnancy. The best time in pregnancy for administering the pertussis vaccination is debated in the literature, with some advocating vaccination in the second trimester and others supporting later vaccination to coincide the time of serum antibody peak with optimum placental transfer. This issue has been considered exclusively from the perspective of serum immunoglobulin G (IgG), but the impact of timing of vaccination in pregnancy on IgA levels in milk may also be important. Previous studies have shown that there is a peak in the pertussis specific IgA in breast milk at day 10 following vaccination, which then declines, and consequently there may be a significant difference in the amount of IgA available in the breastmilk for an infant born to a mother vaccinated at 20 weeks for example, compared to a mother vaccinated at 32 weeks. This may therefore have an impact on future guidelines on optimal time of vaccination in pregnancy.
Study Type
Observational
Primary Outcome
Anti PT IgA at less than 48 hours in colostrum
Secondary Outcome
Total IgA and IgG in colostrum and breastmilk
Condition
Pertussis
Intervention
Boostrix-IPV
Study Arms / Comparison Groups
Women vaccinated at less than 24 weeks
Description: Women receiving a pertussis containing vaccine at less than 24 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
50
Start Date
August 7, 2018
Completion Date
October 31, 2019
Primary Completion Date
August 31, 2019
Eligibility Criteria
Inclusion Criteria: - Singleton pregnancy - Received pertussis vaccination between 16 and 32 gestational weeks - Planning to breastfeed Exclusion Criteria: - Received vaccination outside of the 16-32 week window - Not planning to breastfeed - Diagnosis of an immunodeficiency syndrome - Multiple pregnancy
Gender
Female
Ages
18 Years - N/A
Contacts
Kirsty Le Doare, 02087253887, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT03982732
Organization ID
18.0068
Responsible Party
Sponsor
Study Sponsor
St George's, University of London
Collaborators
European Society for Paediatric Infectious Diseases
Study Sponsor
Kirsty Le Doare, Study Director, St George's, Univeristy of London
Verification Date
June 2019